Method and Device for the Vibrational Mechanical Activation of Composite Materials

ABSTRACT

The invention relates to the field of dentistry and is used for reinforcing composite materials to eliminate various defects of dental hard tissues of carious and non-carious origin in the process of direct/indirect and reinforced/non-reinforced composite restorations. The claimed method includes vibrational mechanical activation of composite materials by vibrationally acting upon portions of composite material shaped by manual mechanical activation (e.g., roll/ball) and applied layer-by-layer to the region of a defect. A device for vibrational mechanical activation of a composite material includes at least one working portion for applying a composite material to the region of a defect, the working portion fixedly attached to a handle, which is connected by a framework to a micromotor that creates vibrations which are transferred via the working portion to a layer of composite material by distributing the same across the entire surface of the defect and achieving the simultaneous surface plastic deformation thereof.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No. 15/082,140, filed on Mar. 28, 2016, which is a continuation-in-part of International Patent Application No. PCT/RU2014/000975, filed on Dec. 23, 2014, which claims priority to and benefit of Russian Patent Application No. 2013147270, filed on Oct. 23, 2013, the disclosures of which are incorporated herein by reference in their entirety.

BACKGROUND

Field

The invention relates to the field of dentistry and can be used to repair defects of dental hard tissues of the carious and non-carious origin, in the process of direct or indirect restorations with reinforced and non-reinforced composites.

Related Art

Continuous development of adhesive technologies facilitated popularization of the usage of composite materials in stomatological practice. Currently, there are many chemical and light curing composite materials.

In clinical practice, light-curing composite materials are widely used to repair various defects of dental hard tissues.

The advantages of modern composite materials are that the composite materials have high physical and mechanical properties, biological inertness, excellent chemical resistance, low shrinkage factor, stronger adhesion, and a better marginal adaptation to the hard tissues of the tooth.

Despite the obvious advantages, composite materials have a number of drawbacks typical to any artificial material used in stomatological practice.

There are a number of complications possible after repairing of defects of dental hard tissues by using composite materials. We distinguish between several classes of the complications that are eliminated in various ways:

Complications of I degree (mild)—the defect of the composite restoration is eliminated by way of polishing, or grinding and polishing;

Complications of II degree (medium)—the defect of the composite restoration is eliminated by way of a partial repeated composite restoration; and

Complications of III degree (severe)—the defect of the composite restoration is eliminated by way of a full repeated composite restoration.

It is found that micro-splits and macro-splits take place after the composite restoration. The methods of split curing are described in the article “The criteria for assessing the quality of the restoration after the repairing of defects of the coronal parts of anterior teeth using composite materials and metal mesh-contoured reinforcing framework” by M. L. Melikyan, G. M. Melikyan, and K. M. Melikyan//Institute of Stomatology.—2011/2.—Pages 86-88.

A split is a partial destruction of the composite restoration.

Micro-splits are insignificant defects of reinforced and non-reinforced composite restorations, which are eliminated by grinding and polishing. Macro-splits are partial defects of reinforced and non-reinforced composite restorations, which are repaired with composite materials.

One of the main reasons for occurrence of splits of composite restorations is large (critical) defects of the type of pores. The porosity of the composite restorations has different nature.

In fact, porosity is an inherent property of any composite material as such. The degree of porosity of composite materials depends on the following factors:

the quantitative ratio of the monomer and the filler;

the method of preparation of the material (when mixing the material, air bubbles are formed, causing porosity); and

the damage of the pre-polymerized filler particles.

Among photopolymer materials, minimal porosity is characteristic of hybrid composites (0.18%-2.5%), more porosity is characteristic of micro-filled materials (0.3%-3.8%) and maximal porosity is characteristic of traditional materials (0.7%-8.4%).

The degree of porosity is increased in the course of restoration. The formation of pores with air bubbles is caused by the manipulations when applying of the composite material during the forming of the composite restoration. The formation of the restoration structure of the tooth consists of adhesion of the composite material to the tooth structure and of adhesion fragments of the restorative material (layer-by-layer technique of restoration forming).

During air-oxygen free polymerization of the portions of the composite, the surface layer is polymerized and forms a strong bond between these portions of the composite.

However, due to the interaction of the applied composite material layer surface with air oxygen, diffusing into the composite, a non-polymerized layer is formed, which is the so-called “oxygen-inhibited layer”. The layer thickness is 20 microns to 30 microns. The polymerization reaction is not possible in the layer, since the formation of the polymer matrix occurs only through the oxygen bonds, which are already occupied with oxygen in this layer.

If there is a non-polymerized layer between the layers of the composite, then the portions of the composite do not join to each other, so the junction interface becomes the place of mechanical weakness of the restoration and subsequent dissection of the restoration under the load of chewing. The results of the spectrographic analysis of the sections of the composite materials confirmed the presence of porosities of a different nature, filled with air bubbles (see Vestnik of the Dniepropetrovsk University, series “Physics. Radio electronics”, 2007, issue 14, No. 12/1).

The classification of pores and their descriptions are given in the article “Analysis of the strength properties of the mesh metal composite materials used in the reinforcement stomatology according to M. L. Melikyan (RDM) (Part 1)” by M. L. Melikyan, K. M. Melikyan, S. S. Gavriushin, K. S. Martirosyan, G. M. Melikyan//Institute of Stomatology.—2012/3.—No. 56—Pages 62-63.

The authors distinguish between two types of micro-pores present in the composite restorations:

closed (internal); and

open blind (external).

Closed micro-pores are inside the restored tooth:

between the hard tissues of the tooth and the adhesive layer;

between the composite material and the adhesive layer;

within the portion of the composite material; and

between the portions of the composite material.

Open blind micro-pores are located on the outer surface of the composite restoration.

According to the Griffith's theory, pores are safe at low loads because they do not tend to increase. At high loads, they may be unstable, capable of rapid growth and merging with each other with the formation of major cracks that lead to the destruction of composite restorations.

According to the mechanical principles, the destruction of the material does not occur simply under the load, but because the load causes a concentration of stress energy that is greater than that the material is capable of accumulating.

Given the fact that one of the main causes leading to the occurrence of splits of the composite restoration are large (critical) defects according to the type of the pores, so the development of technology that will reduce their number and size and, accordingly, will increase the strength of the composite restoration is an urgent task of dentistry. The solution to this problem will allow reducing the number of complications and prolonging the functional life of the composite restoration. The claimed invention is intended to solve this problem.

The solution to this problem, using the prior art methods, reduces to following a certain sequence of making the composite restorations. The following recommended steps of adhesion of portions of the composite are known:

verification of the presence of a surface layer inhibited by oxygen;

introduction of a portion of the composite material;

control test for adhesion;

plastic processing of the introduced portion of the composite material;

control test;

fixation of the form by directed polymerization; and

final polymerization of the portion of the composite material.

It is known from the literature that the main difficulties in applying of the first layer of the composite material to the bottom of the tooth cavity are associated with sticking of the composite to the tool and with the formation of voids between the composite material and the adhesive layer.

Various solutions to this problem were suggested, but the problem still remains actual (J. Sabbagh. “SonicFill™ system: a clinical approach”. Dental Times.—2012.—No. 14.—Pages 6, 8).

To carry out the plastic processing of the applied portion of the composite material, the composite material is spread, with a dental plastic filling instrument, over the prepared surface of the tooth hard tissue that has been coated with an adhesive layer, or over the surface of the previously applied layer of the composite so that there are no air bubbles under it.

The whole surface of the applied portion of the composite is processed with a certain pressure using the dental plastic filling instrument, which ensures squeezing the oxygen-inhibited layer and adhesion of the portion of the composite to the surface at a certain point, which is under pressure at this moment.

The technique of reducing the porosity of the composite material, implemented in the known method, consists of “burnishing” the portion of the composite material by way of the surface plastic deformation, using a sliding tool, over the surface of the deformable material that locally contacts the sliding tool. (“Composite, filling and facing materials”. A. V. Borisenko and V. P. Nespryadko, Kiev, Kniga Plus, 2001). This method does not provide the maximal squeezing of air with the tool out of the pores of the applied composite layer surface.

The disadvantage of this method is that during its implementation the pores are redistributed, as a rule, within the material due to their displacement by the smoothing mechanical action of the tool. At the same time, the insignificant squeezing of the air out of the pores is non-uniform over the entire surface of the deformable material due to the lack of the uniformly controlled force impact of the restoration tool upon the surface of the applied composite material.

In order to reduce porosity and to increase the strength of the composite material, the method of manual mechanical activation (MMA) of the composite material according to M. L. Melikyan is currently used.

Mechanical activation of the composite material means mechanical impact upon the composite material, which leads to an improvement of its physical and mechanical properties.

This method is described in the Russian Patent Nos. 2238696 and 2331385, the patent owners of which are M. L. Melikyan, G. M. Melikyan, K. M. Melikyan.

The essence of the invention according to Russian Patent No. 2238696 lies in that the missing coronal part is restored taking into account the anatomical-topographical and biomechanical peculiarities of the structure of the tooth, which is being restored, using a reinforced mesh metal-composite.

To restore the missing enamel layer, the composite material is roll-shaped by way of manual manipulation by fingers in gloves having textured surface of natural latex without powder. Then, the rolls shaped in this way are used to restore missing walls of the crown part of the tooth.

The essence of the invention according to Russian Patent No. 2331385 lies in the fact that when repairing the defect of the cutting edge up to the depth of 2 mm during the restoration, the composite material is subjected to manual manipulation also when shaping the composite roll.

The patent owners together with scientists from the Bauman Moscow State Technical University investigated the effect of the method of manual mechanical activation (MMA) upon the strength properties of the composite material. The laboratory studies were conducted using the universal testing machine “Quasar 50” (Galdabini, Italy).

The tests were conducted using samples with the dimensions of: length (1) 45 mm, height (a) and width (b) equal to 5 mm for static three-point bending according to the principle: “The concentrated load is applied in the middle of the span”. During the tests, the diagram data on the load deformation—the maximum sag was read, as well as the failure load F_(P) (N), was determined.

To test the static three-point bending, samples of three (3) series of the composite material were made in total amount of 15 pieces (5 pieces in each series). All series of the samples were made at room temperature and were kept in water after their manufacture until the test.

Series I (control series): the portions of the composite material (0.5 g) were measured out by extruding the material out of a syringe, weighed, and introduced into the mould without subjecting to any additional mechanical impact (mechanical activations). To produce samples of series I using a dental plastic filling instrument, a portion of the composite material was extruded out of the syringe and 0.5 g was weighed, and then the portion was placed on the bottom of a polypropylene mould and uniformly distributed over the whole bottom of the mould using the dental plastic filling instrument. Given that the sample was 45 mm long, each composite layer was polymerized 3 times for 20 seconds lengthwise in the polypropylene form, thus the polypropylene form was sequentially filled with the composite material layer by layer and polymerization was carried out.

The ready sample was removed from the mould and control polymerization was carried out from the external surfaces. The weight of the samples was measured using scales with the accuracy of ±0.01 g; the geometric dimensions of the samples were measured with an electronic calliper with the accuracy of ±0.01 mm.

Series II: portions of the composite material (0.5 g) were measured by extruding the material out of a syringe and weighed, and then shaped in the form of balls using the method of manual mechanical impact (mechanical activation). The formed composite balls were put into the mould. In order to make samples of series II using a dental plastic filling instrument, a portion of the composite material was extruded out the syringe and 0.5 g was weighed. Then, the composite material (with the method of mechanical activation) was shaped as balls using the rotational movements of the fingers in medical diagnostic disposable gloves with the textured surface made of natural powder-free latex.

Next, the formed composite ball was placed on the bottom of the polypropylene form and, using the dental plastic filling instrument, it was evenly distributed all over the bottom and polymerization was carried out.

Thus, the polypropylene mould was filled with the composite material sequentially layer by layer. The ready sample was removed from the mould and the control polymerization was carried out from the external surfaces. Further, the weight and revised geometric dimensions of the samples were measured with the accuracy of ±0.01 mm. In the process of measuring, the arithmetic mean values of the sample length, width, and thickness were used.

Series III: differed from series II in that the rolls were formed from the obtained balls (by using the method of mechanical activation). The formed composite rolls were placed into the mould. In order to make samples of series III using a dental plastic filling instrument, a portion of the composite material was extruded out the syringe and 0.5 g of the composite material was weighed. Afterwards, using the rotational movements of the fingers in medical diagnostic gloves, the composite material (by applying the method of mechanical activation) was shaped as balls, and then as rolls. Next, the formed composite roll was placed on the bottom of the mould, and evenly distributed all over the bottom using the dental plastic filling instrument, and polymerization was carried out.

Thus, the polypropylene mould was filled with the composite material sequentially layer by layer. Ready sample was removed from the mould and the control polymerization was carried out from the external surfaces. Further, the weight was measured and the revised geometric dimensions of the samples were measured with the accuracy of ±0.01 mm. In the process of measuring, the arithmetic mean values of the sample length, width, and thickness were used.

Each sample was assigned a serial number and arrows were used to indicate the direction of the load application.

Samples of series I-III were tested for static three-point bending at the temperature of 20° C.

The maximum force generated by the machine is 500 N.

The comparative results, of testing strength characteristics by static three-point bending of the composite samples of series I-III, depending on the testing method, are shown in Table 1.

TABLE 1 Comparative results of the failure force for samples of series I-III made of micro-hybrid composite material. Sample Series Series I Series II Series III Methods Control sample Test sample in Test sample in of making made without the form of a the form of a Samples mechanical composite ball composite roll activation made with made with mechanical mechanical activation activation Maximum Load 168.58 178.28 180.92 F_(max) [N]

The test results for the static three-point bending of the composite samples made of the micro-hybrid composite material revealed that, when the composite material is shaped in the form of a ball (using the method of mechanical activation), the limit load of the sample is increased by 5.7% in comparison with control samples.

By shaping the composite material in the form of a roll (using the method of mechanical activation), the limit load of the sample increases by 7.3% in comparison with control samples (without a roll).

The tests have confirmed that the method of manual mechanical activation of the composite material decreases:

porosity by 30%;

the maximum pore size (critical defects) by 45%; and

the mean pore size by 3%.

The disadvantage of this method of manual mechanical activation lies in that shaping the composite material in the form of a roll in the course of the restoration is applied mainly during the restoration of missing walls of the crown part of the tooth, or during the repairing defects in the cutting edge of the tooth. That is, this method of mechanical activation is used to eliminate some specific defects.

The effect of increasing the strength of the composite restoration, achieved by using the known method, is not sufficient to obtain monolithic composite restoration (MCR).

SUMMARY

The claimed method of reducing porosity and increasing the strength of the composite material is based on the use of a fundamentally new method of its hardening with vibrational mechanical activation (VMA).

In the course of the repairing defects of dental hard tissues using the composite material by way of applying the claimed method, the layers of the composite material are subjected to vibrational impact (vibrational surface plastic deformation). In the process of implementation of the claimed method, each subsequent layer is subjected to vibrational impact prior to its polymerization.

Vibrational surface plastic deformation is vibrational surface plastic deformation of the material due to mechanical vibration of the tool (GOST 18296-72. Surface working. Terms and definitions).

The authors of the invention together with scientists of Bauman Moscow State Technical University conducted studies on the effect of vibrational mechanical activation (VMA) of the composite material on the strength properties of this composite material using test methods described above.

Samples of series I (control samples) made as described above, and samples of series II, which differ from control samples in that during their manufacture each applied layer of the composite material was subjected to vibrational impact with the oscillation frequency of 1000 Hz before polymerization, were tested.

TABLE 2 Comparative results of the failure force for samples of series I-II made of micro-hybrid composite material. Sample Series Series I Series II Methods Control sample Test sample in the of making made without form of a composite samples mechanical activation roll made with mechanical activation Maximum Load 168.58 206.5 F_(max) [N]

The test results for the static three-point bending of the composite samples of series I and series II revealed that the limit load of the samples of series II, made of the micro-hybrid composite material, which was subjected to vibrational impact, increased by 22.5% in comparison with the control samples of series I.

As a result of the subsequent tests conducted together with scientists of the Kazan Federal University (KFU), the dependence of the load limit increase upon the degree of porosity of the micro-hybrid composite material was identified.

In comparison with the control samples of series I, the samples of series II subjected to vibrational mechanical activation feature:

reduction of porosity of the micro-hybrid composite material by 70%;

reduction of the maximal pore size (critical defects) by 45%; and

reduction of the mean pore size by 3%.

In the samples of series II, subjected to vibrational mechanical activation, there are no boundaries at the junction interface between the layers of the composite material.

The advantages of the method of vibrational mechanical activation (VMA) of the composite material according to M. L. Melikyan are as follows:

the load limit increases by 22.5% (without introduction of additional reinforcing elements into the composite material in the process of restoration);

porosity decreases by 70%;

the maximal pore size (critical defects) decreases by 45%; and

the mean pore size decreases by 3%.

The method of vibrational mechanical activation of the composite material is used:

to repair any defects of dental hard tissues; and

for direct, indirect, reinforced, and non-reinforced composite restorations.

The method of vibrational mechanical activation of the composite material ensures:

constant controlled force of the vibrational impact by the restoration tool upon the portion of the composite material and its uniform distribution over the entire defect surface, which was subjected to adhesive processing, or upon the surface of the previously deposited and polymerized composite layer;

the specified direction of vibration impact into the treated surface—perpendicular to the surface of the adhesive layer or the previous layer of polymerized composite material;

effective air squeezing out of the pores (rather than redistribution of pores from the surface of the previously deposited composite layer), and filling them with the composite material;

a significant reduction in the size of critical defects, which reduces the probability of appearance of splits of the composite restoration;

dense and durable adhesion of the composite material to the adhesive layer and to each subsequent portion of the composite material;

forming a solid sealed monolithic composite structure; and

effective marginal adaptation of the composite material to the hard tissues of the tooth, which helps reduce micro-leakages and the formation of secondary caries.

The method of vibrational mechanical activation of the composite material decreases:

the probability of complications and prolongs the operational life of the composite restoration;

retention of dyes by reducing the number and size of open blind micro-pores on the surface of the composite restoration, which ensures high aesthetic quality of the composite restoration;

sorption of water and the formation of bacteria colonies;

the probability of occurrence of pores between the adhesive layer and the composite material, and between the layers of the composite material as the composite material does not stick to the tool; and

the arm muscles tension, which occurs when the force from the hand is transmitted through the tool to a portion of the composite material, is excluded.

The application of the method of vibrational mechanical activation of the composite material allows:

performing restoration without eye and finger strain, including in not easily accessible areas of the tooth; and

shortening the time necessary for the composite restoration due to the effective adhesion of the portion of the composite material to the adhesive or composite layer.

The method of vibrational mechanical activation of composite materials according to M. L. Melikyan is implemented as follows. When repairing a defect of the crown part of the tooth or when eliminating complications of the composite restoration (of degree II and degree III), known methods of layer-by-layer restoration/reconstruction of the crown part of the tooth are applied using the composite materials, which methods have been described, including in the Russian patents for inventions, issued to patent owners M. L. Melikyan, G. M. Melikyan, and K. M. Melikyan (Russian Patent Nos. 2273465, 2331386, 2403886, and 2403887). When implementing the known techniques of layer-by-layer application of composite materials, each subsequent layer of the applied composite material is subjected to vibrational mechanical activation for 20 seconds with the vibration frequency of up to 1000 Hz before polymerization. The permissible level of vibration corresponds to the Sanitary Regulations and Norms (SanPiN), approved by Decree No. 2 of the Goskomsanepidemnadzor State Committee for Sanitary Supervision and Disease Control of the Russian Federation on Jan. 19, 1996.

For the implementation of the claimed method, a special device for vibrational mechanical activation of the composite material is used.

In accordance with an embodiment or aspect, there is provided a method of vibration-based mechanical activation of a composite material in a direct or indirect layered composite restoration of a defect area of a tooth.

The method includes subjecting a portion of the composite material to manual mechanical activation that forms a shaped portion of the composite material, placing the shaped portion atop a portion of polymerized material disposed in the defect area that forms an oxygen-inhibited layer between the shaped portion and the portion of polymerized material in the defect area, applying a vibrational impact to the shaped portion of the composite material such that the shaped portion is distributed in the defect area as a thin layer that undergoes plastic deformation atop the portion of polymerized material and eliminates the oxygen-inhibited layer, and polymerizing the thin layer of the composite material that in combination with the portion of polymerized material forms a monolithic composite structure in the defect area.

The vibrational impact to the shaped portion of the composite material can be applied with an oscillation frequency up to 1000 Hz. Moreover, the shaped portion of the composite material can be subjected to the vibrational impact for at least 20 seconds. It should be noted that the shaped portion of the composite material can be a roll or a ball.

The method can also include applying the vibrational impact to the shaped portion of the composite material perpendicularly to a surface of the portion of polymerized material.

The polymerized material disposed in the defect area can be a polymerized adhesive or a polymerized portion of the composite material.

The method can further include disposing an adhesive in the defect area of the tooth, and polymerizing the adhesive that forms the portion of polymerized material disposed in the defect area.

Yet further, the method can include disposing a first portion of the composite material in the defect area of the tooth, and polymerizing the first portion that forms the portion of polymerized material disposed in the defect area.

Still further, the method can include disposing an adhesive in the defect area of the tooth, polymerizing the adhesive to form a polymerized adhesive disposed in the defect area, disposing a first portion of the composite material as a first thin layer atop the polymerized adhesive, and polymerizing the first thin layer that forms the portion of polymerized material disposed in the defect area.

The disposing of the first portion of the composite material can include subjecting the first portion of the composite material to manual mechanical activation that forms a first shaped portion of the composite material, placing the first shaped portion atop the polymerized adhesive disposed in the defect area that forms a first oxygen-inhibited layer between the first shaped portion and the adhesive in the defect area, and applying a first vibrational impact to the first shaped portion of the composite material such that the first shaped portion is distributed in the defect area as the first thin layer that undergoes plastic deformation atop the polymerized adhesive and eliminates the first oxygen-inhibited layer.

In accordance with an embodiment or aspect, there is provided a device for vibration-based mechanical activation of a composite material in a direct or indirect layered composite restoration of a defect area of a tooth. The device includes a dental plastic filling instrument and a framework.

The dental plastic filling instrument includes a handle and at least one working part. The handle has a tubular body, while the at least one working part is configured to at least place a shaped portion of the composite material to a defect area of the tooth.

The framework is fixedly attached to the handle. Moreover, the framework includes a battery power supply, a micromotor, and an activating element. The activating element is capable of actuating the battery power supply, the battery power supply being electrically connected to the micromotor.

The micromotor is capable of generating a vibrational impact applied via the at least one working part to the shaped portion of the composite material placed atop a portion of polymerized material disposed in the defect area, which causes distribution of the shaped portion in the defect area as a thin layer that undergoes plastic deformation atop the portion of polymerized material, and eliminates an oxygen-inhibited layer between the shaped portion and the portion of polymerized material, wherein the thin layer as polymerized and in combination with the portion of polymerized material forms a monolithic composite structure in the defect area.

The battery power supply and the micromotor can be placed in the framework, wherein the framework can be fixedly attached to the handle with capability of removal from the handle. Moreover, the battery power supply and the micromotor can be placed in the framework, wherein the framework can be fixedly attached inside the handle with capability of removal from the handle.

In some cases, the dental plastic filling instrument can be metal. In other cases, the at least one working part of the dental plastic filling instrument can be metal.

The at least one working part can be fixedly attached to at least one terminal end of the handle. Moreover, the at least one working part can include a ball or a paddle.

The vibrational impact can have an oscillation frequency up to 1000 Hz.

BRIEF DESCRIPTION OF THE DRAWINGS

A better understanding of this invention will be had by now referring to the accompanying drawings in which: FIG. 1 is a view of a first embodiment of the special device for vibrational mechanical activation of the composite material crowns in accord with the present invention; and

FIG. 2 is a view of a second embodiment of the special device for vibrational mechanical activation of the composite material crowns in accord with the present invention;

DETAILED DESCRIPTION

The device illustrated in FIGS. 1 and 2 includes a handle 1, for example, in the form of a tubular body, at one end or at both ends of which one or two working elements 2 are fixedly attached and used for applying a portion of the composite material to the defect area of the crown part of the tooth and its distribution over the defect surface using vibrational impact. The design of the device and the working elements 2 are similar to the known dental plastic filling instrument, wherein the device or one or two working elements 2 can be made of metal. As illustrated in the figures, the dental plastic filling instrument is double-ended, with a first working element 2 in a shape of a ball and an opposite second working element 2 in a shape of a paddle.

The handle 1 includes a fixing device—a removable framework 3—for fixating the battery power supply 6 and a micro-motor 5, which is connected to the power supply 6 and generates vibration. There is a button 4 of the actuating element placed on the handle 1 for switching the power supply 6 on/off by pressing the button 4.

The embodiments of the device provide for placing the power supply 6 and the micro-motor 5 outside the handle 1 (FIG. 1) or inside the tubular body of the handle 1 (FIG. 2).

In the embodiment of FIG. 1, in order to fix the power supply 6 and the micro-motor 5 outside the tubular body, the removable framework 3 with finger grips is used as the fixing device. The battery power supply 6 and the micro-motor 5 are fixed internally to the framework 3.

In the embodiment of FIG. 2, with the location of the framework 3 inside the tubular body of handle 1, a window may be provided in the inner wall of the tubular body, for the internal placement of the battery power supply 6 and of the micro-motor 5. The framework 3 is fixed in an opening to the window by interference fit.

In cases of the internal and external placement of the removable framework 3, the framework 3 serves as a cover that insulates the battery power supply 6 and the micro-motor 5 from the external environment. In case the battery power supply 6 should be replaced, the framework 3 is taken off or out, the spent battery is removed and replaced with a new one.

The device for vibrational mechanical activation of the composite material operates as follows.

A portion of the composite material is applied, using the working element 2, to the surface in the area of the defect of the crown part of the tooth.

Using button 4 of the actuating element, the power supply 6 is switched on and electrically connected to the micro-motor 5. The activated micro-motor 5 generates vibrations that are transmitted to the working element 2, whereby vibrational mechanical activation of the deposited layer of the composite material is performed. The composite material is distributed under the impact of this vibration over the entire surface of the defect and is simultaneously subjected to surface plastic deformation for no less than 20 seconds. Then, using button 4 of the actuating element, the power supply 6 is switched off. The device returns to the static condition and is ready for the application of the next portion of the composite material.

After the vibrational impact has been completed, the layer of the composite material that has been subjected to the vibrational mechanical activation is polymerized in a conventional manner.

Then, a new portion of the composite material is applied, which is subjected to vibrational mechanical activation in accordance with the procedure described above. The operations of applying portions of the composite material, the vibrational impact, and polymerization are repeated until the full restoration of the integrity of the hard tissues of the tooth.

While the invention has been particularly shown and described as referenced to the embodiments thereof, those skilled in the art will understand that the foregoing and other changes in form and detail may be made therein without departing from the spirit and scope of the invention. 

1. A method of vibration-based mechanical activation of a composite material in a direct or indirect layered composite restoration of a defect area of a tooth, the method comprising: subjecting a portion of the composite material to manual mechanical activation that forms a shaped portion of the composite material; placing the shaped portion atop a portion of polymerized material disposed in the defect area that forms an oxygen-inhibited layer between the shaped portion and the portion of polymerized material in the defect area; applying a vibrational impact to the shaped portion of the composite material such that the shaped portion is distributed in the defect area as a thin layer that undergoes plastic deformation atop the portion of polymerized material and eliminates the oxygen-inhibited layer; and polymerizing the thin layer of the composite material that in combination with the portion of polymerized material forms a monolithic composite structure in the defect area.
 2. The method according to claim 1, wherein the vibrational impact to the shaped portion of the composite material is applied with an oscillation frequency up to 1000 Hz.
 3. The method according to claim 1, wherein the shaped portion of the composite material is subjected to the vibrational impact for at least 20 seconds.
 4. The method according to claim 1, wherein the shaped portion of the composite material is a roll or a ball.
 5. The method according to claim 1, further comprising applying the vibrational impact to the shaped portion of the composite material perpendicularly to a surface of the portion of polymerized material.
 6. The method according to claim 1, wherein the polymerized material disposed in the defect area is a polymerized adhesive or a polymerized portion of the composite material.
 7. The method according to claim 1, wherein the method further comprises: disposing an adhesive in the defect area of the tooth; and polymerizing the adhesive that forms the portion of polymerized material disposed in the defect area.
 8. The method according to claim 1, wherein the method further comprises: disposing a first portion of the composite material in the defect area of the tooth; and polymerizing the first portion that forms the portion of polymerized material disposed in the defect area.
 9. The method according to claim 1, wherein the method further comprises: disposing an adhesive in the defect area of the tooth; polymerizing the adhesive to form a polymerized adhesive disposed in the defect area; disposing a first portion of the composite material as a first thin layer atop the polymerized adhesive; and polymerizing the first thin layer that forms the portion of polymerized material disposed in the defect area.
 10. The method according to claim 9, wherein disposing the first portion of the composite material comprises: subjecting the first portion of the composite material to manual mechanical activation that forms a first shaped portion of the composite material; placing the first shaped portion atop the polymerized adhesive disposed in the defect area that forms a first oxygen-inhibited layer between the first shaped portion and the adhesive in the defect area; and applying a first vibrational impact to the first shaped portion of the composite material such that the first shaped portion is distributed in the defect area as the first thin layer that undergoes plastic deformation atop the polymerized adhesive and eliminates the first oxygen-inhibited layer.
 11. A device for vibration-based mechanical activation of a composite material in a direct or indirect layered composite restoration of a defect area of a tooth, the device comprising: a dental plastic filling instrument comprising a handle and at least one working part, the handle having a tubular body, the at least one working part configured to at least place a shaped portion of the composite material to a defect area of the tooth; and a framework fixedly attached to the handle, the framework comprising a battery power supply, a micromotor, and an activating element, the activating element capable of actuating the battery power supply, the battery power supply electrically connected to the micromotor, the micromotor capable of generating a vibrational impact applied via the at least one working part to the shaped portion of the composite material placed atop a portion of polymerized material disposed in the defect area that causes distribution of the shaped portion in the defect area as a thin layer that undergoes plastic deformation atop the portion of polymerized material and eliminates an oxygen-inhibited layer between the shaped portion and the portion of polymerized material, wherein the thin layer as polymerized and in combination with the portion of polymerized material forms a monolithic composite structure in the defect area.
 12. The device according to claim 11, wherein the battery power supply and the micromotor are placed in the framework, the framework fixedly attached to the handle with capability of removal from the handle.
 13. The device according to claim 11, wherein the battery power supply and the micromotor are placed in the framework, the framework fixedly attached inside the handle with capability of removal from the handle.
 14. The device according to claim 11, wherein the dental plastic filling instrument is metal.
 15. The device according to claim 11, wherein the at least one working part of the dental plastic filling instrument is metal.
 16. The device according to claim 11, wherein the at least one working part is fixedly attached to at least one terminal end of the handle.
 17. The device according to claim 11, wherein the at least one working part comprises a ball or a paddle.
 18. The device according to claim 11, wherein the vibrational impact has an oscillation frequency up to 1000 Hz. 